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Under the Federal Food, Drug and Cosmetic Act, the FDA has the authority to inspect clinical investigators, IRBs, sponsors, monitors, contract research organizations, and any other entities that submit to the FDA clinical data or information in applications for approval to market investigational drugs, devices or other test articles.

If you are contacted by the FDA regarding an inspection, you should contact the OIRB by phone and follow up with a written notification to the IRB giving the Principal Investigator and title of the study to be inspected.

Any report regarding the audit should be forwarded to the OIRB within 2 weeks of receipt by the investigator and/or study coordinator.‚Äč